This invention relates to a device for surgically repairing soft tissues and a method for making the same.
Certain problems are encountered in attempting to surgically repair soft tissue. The term "soft tissue" refers to tissue located between the skin (but not the skin itself) and organs or bone. An example of a situation where repair of soft tissue is accomplished is in the repair of a hernia.
Prior devices utilized for repairing soft tissue include various types of mesh material or woven fabric which are stitched in covering relation over the area to be repaired. Various types of substances have been used for these fabrics including steel, Nylon.RTM., Teflon.RTM., Dacron.RTM., and polypropylene. These materials have been used in a woven fabric or mesh, particularly for hernia repairs, for many years.
These various meshes have several disadvantages. Steel mesh does not have a flexible characteristic similar to the flexibility of the body, and therefore it feels uncomfortable during flexing or movement of the body. Furthermore, the steel does not decompose over a period of time.
Nylon.RTM. has been used, but this material has a very slight hostility to the body. As a result, the body does not form satisfactory tissue growth around the nylon.RTM. so as to provide a natural healing of the hernia or injury.
Polypropylene is relatively inert to the body, but does not have a sufficient strength for use over a period of time. The new growth tissue encapsulates the polypropylene but is fairly thin and grows in a disorganized manner. After several years of flexing, the polypropylene sometimes will fracture and the fibrous tissue which has formed over the polypropylene is not sufficiently strong to prevent a reoccurrence of the hernia.
Therefore a primary object of the present invention is the provision of an improved device for surgically repairing soft tissues and a method for making the same.
A further object of the present invention is the provision of an improved device which has improved tensile strength over devices previously used.
A further object of the present invention is the provision of an improved device which stimulates fibrotic tissue growth in an organized pattern so that the fibrotic tissue growth eventually will support the hernia or injury independently of the fabric which forms the device.
A further object of the present invention is the provision of a device which when stitched to the body has a flexibility which is compatable with the body so as to minimize discomfort to the patient.
A further object of the present invention is the provision of a device which when stitched to the body is of light weight so as to minimize discomfort to the patient.
A further object of the present invention is the provision of a device which permits the body to heal itself so that when the device itself breaks or decomposes, the fibrous tissue formed by the body will maintain the repair.
A further object of the present invention is the provision of a device which stimulates fibrotic tissue growth quickly so that the fibrotic tissue is self repairing within approximately sixty to ninety days after application of the device.
A further object of the present invention is the provision of a device which is economical to manufacture, durable in use, and efficient in operation.